{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-45K",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-45K.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/45K",
  "kind": "regulation",
  "number": "45K",
  "heading": "Offences: breach of regulations and false information",
  "text": "(1) A person is guilty of an offence if the person—\n(a) contravenes regulation 45A(1); or\n(b) brokers a medicinal product otherwise than in accordance with the criteria under regulation 45E relating to that person’s brokering registration.\n(2) A person is guilty of an offence if the person knowingly gives false information in—\n(a) an application for a broker registration under regulation 45B(2);\n(b) a notification to the licensing authority under regulation 45F(4);\n(c) an application for a variation under regulation 45J(1); or\n(d) response to a notice under regulation 45C(3) or 45J(5).\n(3) A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 45F(6) or 45J(5).",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Pt. 3 Chs. 3, 4 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 16"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/45K",
    "retrieved_at": "2026-10-29T01:24:34.993203+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}